CRO Quintiles has signed a five-year agreement to use OmniComm Systems' technology for Phase I clinic automation.
After what it described as a “thorough evaluation of commercially available Phase I software,” Quintiles' early clinical development selected OmniComm's TrialOne software to replace its legacy Phase I Clinical Trial Development System (PICTS).
This is part of a company-wide initiative to standardize Quintiles global Phase I clinics on one technology. The software will be initially implemented across Quintiles’ early clinical development clinics in the UK and US.
Oren Cohen, Global Head of Early Clinical Development, told Outsourcing-Pharma.com, “The agreement with OmniComm is a new one. We will be moving from our current technology platform to the OmniComm platform.
“One of the important advantages of the OmniComm platform is that it is web-based. This will enable us to work seamlessly on the increasing number of trials that we do across multiple sites, in patient populations as well as in normal healthy volunteers.
“The new platform will be applied to all types of trials done in our business, including first-in-human trials; clinical pharmacology and PK studies; bioavailability, bioequivalence and ADME studies; drug-drug and drug-food interaction studies; thorough QT studies; and others,” Cohen added.
TrialOne's architecture will also allow for easier integration with Quintiles’ Infosario analytics platform. Client-specific data libraries can be developed and segregated for quick study start-up or to adjust clients' data specifications.
As Quintiles transitions to more patient studies in early development, data capture can occur from any location that has internet access, allowing the company to utilize hospital and external site settings without resorting to paper case report forms.
"OmniComm is delighted to add Quintiles to our growing list of TrialOne clients," said Randy Smith, OmniComm's CTO and TrialOne Group Executive Sponsor. "TrialOne's comprehensive functionality and global deployment will allow Quintiles to realize operational efficiencies which will translate into superior service and faster, industry data for Quintiles and their clients."